Novartis attacked by US senators over its ‘unconscionable’ handling of Zolgensama data


US democrat hopefuls Bernie Sanders and Elizabeth Warren have both attacked Novartis over its handling of its gene therapy data.

Zolgensama was thrust into the spotlight last week, when the FDA announced news around the data manipulation that occurred around one of the pre-clinical trials for Zolgensama. To provide a short summary, according to the FDA, AveXis ( the Novartis subsidiary that makes Zolgensama) knew 2 months before approval that data had been manipulated and did not admit to the FDA until one month after approval.

Novartis has since defending itself regarding the allegations, stating that it is still ‘fully confident in the safety, quality and efficacy of Zolgensama’ referencing to how the data manipulation only applies ‘to a small portion of the product testing data’ in relation to the animal subjects and not the humans. With the assays ( activity tests) under scrutiny only being used for product testing and not currently used for commercial product release.

This however has not stopped senators from attacking Novartis, with senators writing “ It is unconscionable that a drug company would provide manipulated data to federal regulators in order to rush its product to market, reap federal perks and charge the highest amount in American history for its medication. Such greed cannot be condoned by the FDA. This scandal smacks of the pharmaceutical industry’s privilege and greed and Americans are sick of it.”

This may seem like a very aggressive attack on an issue that when is analysed in further detail may not warrant such a response, but this ‘attack’ by senators is no doubt further fueled by the price Novartis set for the gene therapy. At $2.1m, the rare disease therapy is the most expensive drug in American history. And as Sanders and the other senators see it, this data manipulation was a result of AveXis rushing to start selling the gene therapy at this price. The senators are annoyed even further due to the US federal support AveXis received for Zolgensama. With the letter going on to further highlight the fast tracking, breakthrough and priority review perks Zolgensama received from the FDA.

The involvement of senators in this issue may result in a situation which Novartis will not be able to brush away so easily, with the senators most likely wanting now to know why the FDA withdrew a proposed regulation covering the prompt reporting of suspected data falsification. It seems Novartis will be in for a tough ride these coming months.


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